BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2973561 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-02240
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. REFERENCE MFR REPORTS: 1627487-2013-02238 AND 1627487-2013-02239. THE PATIENT HAS TWO SYSTEMS, ONE IN THE THORACIC REGION AND THE OTHER IS FOR OCCIPITAL NERVE STIMULATION (OFF-LABEL). IT WAS REPORTED THE PATIENT FELT A "ZAPPING JOLT" TWICE WHEN SHE TRIED CHARGING THE IPG FOR HER THORACIC SCS SYSTEM. SHE STARTED SHE ALSO FELT THE SENSATION WHEN SHE ARCHED HER BACK. SHE REPORTED SHE NOW FEELS A "CRAWLY" SENSATION THAT WRAPS AROUND HER SIDE DURING CHARGING. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72463 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3817710

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788| SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3159 (4)| IMPLANT DATE:| SCS EXTENSION, MODEL 3341